PrEP Intervention for People Who Inject Substances and Use Methamphetamine

NCT04523519 | Recruiting Phase 4 DMC

• 1 other identifier: R01DA051850
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We will randomize 140 adults who use methamphetamine, are HIV-negative, and have recently engaged in a sexual HIV risk behavior to VDOT-CM or counseling alone for 24 weeks. The study aims are to (1) determine the efficacy of VDOT-CM compared to counseling alone for PrEP adherence, (2) evaluate the acceptability of PrEP and adherence support strategies among the cohort, and (3) compare injection or chemsex and sexual HIV risk behavior before and during PrEP use. We hypothesize that participants randomized to VDOT-CM will have superior adherence to PrEP. We also hypothesize that participants will describe barriers to and facilitators of PrEP adherence, and those who are randomized to VDOT-CM will consider it an acceptable PrEP adherence support strategy. Finally, we do not expect to find increased injection, chemsex, or sexual risk behaviors for HIV among study participants after they begin taking PrEP.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• Tenofovir diphosphate (TFV-DP) levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots

  Week 6

• TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots

  Week 12

• TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots

  Week 18

• TFV-DP levels ≥175 fmol/punch or >= 950 fmol/punch in dried blood spots

  Week 24

Secondary Outcomes (5)

• Qualitative interview data describing participant experiences taking PrEP, with Integrated Next-Step Counseling, and among those randomized to the VDOT-CM arm, experience with VDOT-CM

  Interviews done at end of study (24 weeks)

• SexPro score

  Change in SexPro score from baseline at 12 weeks

• SexPro score

  Change in SexPro score from baseline at 24 weeks

• ARCH-IDU Score

  Change in ARCH-IDU score from baseline at 12 weeks

• ARCH-IDU Score

  Change in ARCH-IDU score from baseline at 24 weeks

Study Arms (2)

Video directly observed therapy with contingency management

EXPERIMENTAL

Video directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling.

Behavioral: Video directly observed therapy with contingency management; Behavioral: Integrated Next-Step Counseling

Integrated Next-Step Counseling

PLACEBO COMPARATOR

Behavioral: Integrated Next-Step Counseling

Interventions

Video directly observed therapy with contingency management BEHAVIORAL

PrEP adherence will be assessed by visual recognition software during video capture and reviewed for confirmation by study staff, ensuring that videos demonstrate study medication dosing by participant. Participants will receive small financial incentives upon confirmation of dosing.

Video directly observed therapy with contingency management

Integrated Next-Step Counseling BEHAVIORAL

Integrated Next-Step Counseling combines support for behavioral strategies that reduce sexual and injection-related HIV risk and do not involve PrEP, with strategies to support PrEP adherence in brief, client-centered conversations.

Integrated Next-Step Counseling; Video directly observed therapy with contingency management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age 18-65 years inclusive,
• Assigned male sex at birth,
• Past 30-day methamphetamine use on 4 or more days, by self-report,
• ≥ 1 positive methamphetamine urine toxicology,
• Either interested in initiating PrEP OR currently on daily PrEP with sub-optimal adherence (measured as missing at least one dose of one's PrEP in the past 30 days, by self-report),
• Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months,
• HIV-negative,
• Reliable access to a computer to complete study visits, if participating remotely, AND
• Proficient in English

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• On PrEP for more than 6 months,
• Unwillingness to use a video app to record oneself taking PrEP, OR
• Any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial.
• Contraindication to tenofovir or emtricitabine-containing products,
• Creatinine clearance ≤30 mL/min, OR
• Positive hepatitis B surface antigen test.

Sponsors & Collaborators

• San Francisco Department of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

RECRUITING

Related Publications (11)

• Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published 2018. Accessed November 1, 2019

  BACKGROUND

• San Francisco Department of Public Health. HIV Epidemiology Annual Report 2018. San Francisco Department of Public Health. https://www.sfdph.org/dph/files/reports/RptsHIVAIDS/HIV-Epidemiology-Annual-Report2018.pdf. Published 2019. Accessed November 4, 2019.

  BACKGROUND

• Degenhardt L, Mathers B, Guarinieri M, Panda S, Phillips B, Strathdee SA, Tyndall M, Wiessing L, Wodak A, Howard J; Reference Group to the United Nations on HIV and injecting drug use. Meth/amphetamine use and associated HIV: Implications for global policy and public health. Int J Drug Policy. 2010 Sep;21(5):347-58. doi: 10.1016/j.drugpo.2009.11.007. Epub 2010 Feb 1.

  PMID: 20117923 BACKGROUND

• HIV/AIDS Epidemiology Unit, Public Health - Seattle & King County and the Infectious Disease Assessment Unit, Washington State Department of Health. HIV/AIDS Epidemiology Report & Community Profile 2019, Volume 88.

  BACKGROUND

• Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

  PMID: 21091279 BACKGROUND

• Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.

  PMID: 23769234 BACKGROUND

• Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Curlin ME, Na-Pompet S, Warapronmongkholkul A, Kittimunkong S, Gvetadze RJ, McNicholl JM, Paxton LA, Choopanya K; Bangkok Tenofovir Study Group. The impact of adherence to preexposure prophylaxis on the risk of HIV infection among people who inject drugs. AIDS. 2015 Apr 24;29(7):819-24. doi: 10.1097/QAD.0000000000000613.

  PMID: 25985403 BACKGROUND

• Storholm ED, Volk JE, Marcus JL, Silverberg MJ, Satre DD. Risk Perception, Sexual Behaviors, and PrEP Adherence Among Substance-Using Men Who Have Sex with Men: a Qualitative Study. Prev Sci. 2017 Aug;18(6):737-747. doi: 10.1007/s11121-017-0799-8.

  PMID: 28578516 BACKGROUND

• Finlayson T, Cha S, Xia M, Trujillo L, Denson D, Prejean J, Kanny D, Wejnert C; National HIV Behavioral Surveillance Study Group. Changes in HIV Preexposure Prophylaxis Awareness and Use Among Men Who Have Sex with Men - 20 Urban Areas, 2014 and 2017. MMWR Morb Mortal Wkly Rep. 2019 Jul 12;68(27):597-603. doi: 10.15585/mmwr.mm6827a1.

  PMID: 31298662 BACKGROUND

• Chen YH, Guigayoma J, McFarland W, Snowden JM, Raymond HF. Increases in Pre-exposure Prophylaxis Use and Decreases in Condom Use: Behavioral Patterns Among HIV-Negative San Francisco Men Who have Sex with Men, 2004-2017. AIDS Behav. 2019 Jul;23(7):1841-1845. doi: 10.1007/s10461-018-2299-7.

  PMID: 30306436 BACKGROUND

• McMahan VM, Pope E, Luna Marti X, Walker J, Liu AY, Coffin PO. Interest in Long-Acting Preexposure Prophylaxis (PrEP) Among Men at Risk for Human Immunodeficiency Virus Who Use Methamphetamine Participating in a Daily, Oral PrEP Adherence Trial in San Francisco, California. Open Forum Infect Dis. 2025 May 12;12(5):ofaf280. doi: 10.1093/ofid/ofaf280. eCollection 2025 May.

  PMID: 40406373 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Phillip Coffin

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip Coffin, MD

CONTACT

628-217-6282; phillip.coffin@sfdph.org

Vanessa McMahan, PhD

CONTACT

628-217-7469; vanessa.mcmahan@sfdph.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Research

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: April 30, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)